January 3, 2007 - Effective with the February 5, 2007 submission date, all R01 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Accordingly, this funding opportunity expiree on September 22, 2006. Unsolicited or investigator-initiated R01 electronic SF424 (R&R) applications may be submitted through the Research Project Grant (Parent R01) announcement.

The goal of this initiative is to provide funding opportunities for the increasing pool of foreign biomedical and behavioral scientists, clinical investigators, nurses, and other health professionals with state-of-the-art knowledge of research methods to advance critical issues in global health upon their return to their home countries through behavioral and social sciences research.

The total amount to be awarded is $500,000 and the anticipated number of awards is ten to 15.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary, however, individual awards are limited to a maximum of $50,000 direct costs per year. The total amount awarded and the number of awards will depend upon the quality and costs of the applications received.

This PA will use the NIH Research Project Grant (R01) award mechanism, using the modular grant format.

Eligible organizations include: for-profit or non-profit organizations; public or private institutions; units of state and local governments of developing countries; faith-based or community-based organizations.

Eligible Principal Investigators include individuals from eligible institutions who: (a) have at least two years of research training experience under an FIC-supported training grant; (b) have one year of such D43 training experience coupled with one year of significant, well-documented mentored research experience; (c) one year of the NIDA INVEST Fellowship plus one or more years of mentored research; or (d) at least two years of research training experience through the NIH intramural Visiting Fellows Program.

Only one application will be accepted per applicant per submission date.

The Principal Investigator (PI) is expected to devote at least 50 percent of his/her total effort to this project.

This PAR is intended to promote productive re-entry of foreign investigators from low-income countries, trained in the U.S., into their home countries. This program will use several specific mechanisms, including training in the intramural program at NIH, through Fogarty International Center research and training program, NIDA INVEST Fellowships, and the Human Frontier Science Program, as part of a broader program to enhance the scientific research infrastructure in developing countries, to stimulate research on a wide variety of high priority health-related issues in these countries, and to advance NIH efforts to address health issues of global import.

The specific goal of this initiative is to provide funding opportunities for the increasing pool of foreign social and behavioral scientists, clinical investigators, nurses, and other health professionals, upon their return to their home countries, with state-of-the-art knowledge of research methods to advance critical issues in global health through behavioral and social sciences research.

After their term of research training, developing country participants supported by this PAR are expected to continue independent and productive scientific careers, including expert training and consultation, and/or research of behavioral issues within their home institutions.

This PAR contributes to the FIC mission and the broad NIH initiative to reduce health disparities among nations by strengthening research infrastructure in developing countries, particularly those with the least economic resources. It also provides the opportunity for recently trained international health and health care researchers to continue their projects after returning home.

Definitions of “behavioral” and “social”: For purposes of this initiative, the term “behavioral” refers to overt actions; to underlying psychological processes such as cognition, emotion, temperament, and motivation; and to biobehavioral interactions. The term “social” encompasses sociocultural, socioeconomic, and sociodemographic status; to biosocial interactions; and to the various levels of social context from small groups to complex cultural systems and societal influences.

The core areas of behavioral and social sciences research are those that have a major and explicit focus on the understanding of behavior and social processes, or on the use of these processes to predict or influence health outcomes or health risk factors. These core areas of research are divided into basic (or fundamental) research and clinical research.

As part of its global health initiative under the Department of Health and Human Services (DHHS), the Fogarty International Center (FIC) of the National Institutes of Health (NIH), in partnership with the following Institutes, Centers and Offices on this PAR: National Eye Institute (NEI); National Heart, Lung and Blood Institute (NHLBI); National Institute on Drug Abuse (NIDA); National Institute of Environmental Health Sciences (NIEHS); National Institute of General Medical Sciences (NIGMS); Office of Behavioral and Social Sciences Research (OBSSR); Office of Dietary Supplements (ODS); and Office of Research on Women's Health (ORWH), invites applications from current and former NIH-supported foreign research trainees to compete for funds that will support their research efforts upon return to their home countries. In order to be eligible, foreign scientists must meet at least one of the following criteria:

At least two years of research training experience under an FIC-supported training grant (classified by the D43 “International Training Grant” mechanism).

One year of such D43 training experience coupled with one year of significant, well documented mentored research experience (e.g., through an NIH research award such as the NIAID Small Research (R03) (IRID-NIAID) program).

At least two years of research training experience through the NIH intramural Visiting Fellows Program.

One year of training through an F05 international fellowship program and one subsequent year of mentored research.

Recipients of Long Term Fellowship awards through the Human Frontier Science Program, who come from low- and middle-income countries, and who have spent at least two years in research training.

At least one year of training in the U.S. and one additional year of significantly mentored research, in the U.S. or abroad, leading to a completed master's degree or doctoral degree, at least partially funded through a Fogarty International Center research training program, with pre-approval by the program director.

All training and research must either have been done in the U.S. or have been part of in-country research associated with a degree or mentored post-doctoral research under the D43 award mechanism and completed within three years of the receipt date of this PAR.

Candidates who are more than five years beyond their training, but who have interrupted their careers because of illness or family commitments, may also apply. They must clearly demonstrate the potential for productive independent research.

Current NIH Visiting Fellows are encouraged to apply in a timely fashion, i.e., as they begin their preparation to return home. They, as all applicants, may apply within three years of completing training.

Through various programs, the NIH has made a significant investment in training biomedical and behavioral researchers. For example, the NIH Visiting Fellows Program currently hosts more than 1,600 junior scientists from almost 100 countries for periods of one to five years. In addition, the NIH D43 research training and capacity building grant mechanism allows hundreds of foreign researchers to receive training at prominent institutions in both the United States and their home countries in a range of biomedical and behavioral research areas critical to advancing global health. In summary, training supported by NIH is critical to these young investigators as they develop independent research careers.

As junior scientists complete training programs in the U.S., many find it difficult to secure the support needed to continue their research projects and careers in their home countries. This Global Research Initiative Program (GRIP) provides the opportunity for junior foreign scientists to compete for such funds through a peer-reviewed process. This is a critical adjunct in the continuation of promising independent research careers that will be of benefit to the investigators' home countries and the world at large. Women and underrepresented minority scientists in their countries are especially encouraged to apply for these re-entry grants. Project proposals should be geared toward the research interests of the applicant and focus on high-priority health and health care problems in the investigator's home country that also carry global importance, and are of interest to the collaborating NIH Institutes, Centers, and Offices (ICs) listed on the first page of this PAR, as well.

It is expected that research topics will be diverse. Specific research interests of partnering ICs can be found on the ICs' websites, as listed in the beginning of this PAR. Research related to women's health, including studies of gender differences in disease onset and progression, identification of behavioral strategies that are effective in encouraging healthy lifestyles in young girls and women, as well as behavioral strategies to encourage prevention of diseases such as STDs and diseases with higher prevalence among women (including infectious diseases, lupus, multiple sclerosis and depression) are particularly encouraged. Research on healthy outcomes of pregnancy and child survival, and population research as associated with both behavioral and social, and economic research is encouraged. Research related to the health effects of human exposures to environmental agents is encouraged. Research focused on behavioral and social determinants and their effects on health is also encouraged. All research must be performed in accordance with NIH and U.S. Government regulations regarding the responsible conduct of research. This PAR precludes the support of research involving enrollment in pilot studies for clinical trials or the actual support of clinical trials since the resources and infrastructure to support and oversee such trials generally exceed the resources available under this award mechanism. Applicants are encouraged to visit the website of the Office for Human Research Protection (OHRP) http://www.hhs.gov/ohrp/, that outlines these regulations. For information on animal protection in research, see http://grants.nih.gov/grants/olaw/olaw.htm.

This PAR contributes to the FIC mission and to the broad NIH initiative to reduce the health disparities among nations by strengthening research infrastructure in developing countries, particularly those with the least economic resources. Additionally, it provides the opportunity for recently trained international health and health care researchers to continue their projects after returning home.

Evaluation of the program will occur on an ongoing basis. Because this is a program to move research trainees to the status of independent investigator, there are several outcomes to be measured:

Development of the laboratory capabilities or research projects

Training of other potential researchers

Publications in local journals, as well as international peer-reviewed journals

Participation in workshops, seminars, and international conferences

Collaborations with past mentors, as well as others

Attraction of funding from other sources

As part of its assessment of the impact and scientific productivity of this program, FIC plans to track researchers and their trainees for at least five years after beginning their independent research. Evaluation may focus on the success of researchers (as measured by the number and quality of publications, presentations, courses, awards, subsequent employment, etc.), their sustained commitment to research careers, their ability to attract funding for their work, their contributions to future international collaborations, their influence on the development of scientific research in their countries, and their ability to act as consultants, teachers and role models to other local investigators and further disseminate the lessons learned. Metrics should be stated both for the success of the individual researcher and the success in capacity building at the home institution, including the impact of the program on research at the institution in the home countries of researchers and their trainees.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the R01 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

An applicant can request up to two modules of $25,000 each, or total direct costs of $50,000 per year, plus facilities and administrative (F & A) costs to a maximum of eight percent for a foreign institution.

Applications in response to this PAR may have a project period of no less than three years and no more than five years. Because an investigator can receive a maximum of five years of support under the GRIP program, and this specific GRIP award is not renewable, any future application will be considered to be an unsolicited competing application based on this project and will compete with all investigator-initiated applications submitted to NIH through the Center for Scientific Review (CSR).

The earliest anticipated start date for these awards is July of the year following the receipt date.

Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

For-profit organizations in developing countries

Non-profit organizations in developing countries

Public or private institutions, such as universities, colleges, hospitals, and laboratories, in developing countries

Units of State government of developing countries

Units of local government in developing countries

Faith-based or community-based organizations in developing countries

Only institutions in developing countries are eligible to apply. Institutions in countries that have the least economic resources are particularly encouraged to apply. For the purpose of this PAR, institutions in the following countries or geographical regions are eligible: North Africa, West Africa, East Africa, Central Africa, Southern Africa, Russia, the Newly Independent States, Eastern Europe, the Middle East (except Israel), India, Asia (except Japan, Singapore, South Korea and Taiwan), the Pacific Islands regions (except Australia and New Zealand), Latin America and the Caribbean.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

Only applicants from institutions in eligible countries may apply.

FIC strongly encourages applications from women and individuals from underrepresented racial, ethnic and socially disadvantaged groups. Where appropriate, the design of projects should take into account potential sex and gender differences that may affect the questions asked and the analyses performed. These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies

In order to be eligible, applicants must meet at least one of the following criteria:

at least two years of research training experience under an FIC-supported training grant (classified by the D43 “International Training Grant” mechanism);

one year of such D43 training experience coupled with one year of significant, well-documented mentored research experience (e.g., through an NIH research award such as the NIAID Small Research (R03) (IRID-NIAID) program);

one year of the NIDA INVEST Fellowship plus at least one additional year of mentored research;

at least two years of research training experience through the NIH intramural Visiting Fellows Program;

at least two years of training through the Human Frontiers Science Program, and come from and return to a low- or middle-income country;

at least one year of training through an F05 grant program with at least one further year of significant mentored training, either here in the U.S. or abroad;

at least two years of training through a Fogarty International Center Research Training Program leading to completion of a master's or doctoral degree, funded at least in part through the FIC program funds.

All training and research, to meet eligibility requirements, must have either been done in the U.S. or have been part of in-country research associated with a degree or mentored post-doctoral research under the D43 award mechanism, and completed within three years of the receipt date of the PAR.

Applicants must return to a research position in their home country institution in order to carry out research supported by this award. The award will be made to the home institution on the investigator's behalf only after the investigator has arrived in that country. Therefore, the application must be submitted by the institution to which the applicant has returned or will be returning. It is expected that the PI will demonstrate that he/she has an appointment at an academic or other institution in his/her home country and will demonstrate or provide a letter of support indicating that the institution will have the capacity to support the research proposed. The GRIP award will support up to one-half the investigator's salary, commensurate with the salary structure of the home institution. Funds from the institution, national government, local science research council or other public or private organization may be used to support this program. The remainder of the funds from this grant may pay for equipment, travel, supplies, or other research personnel's salary working on the same project.

In order to build upon experience, partnership, mentorship and prior investments, applicants are encouraged to submit applications in collaboration with the NIH-supported institution or intramural laboratory from which they have received or are receiving research training. Through letters of support, U.S. collaborators should demonstrate how this program will support ongoing research collaborations. For those applicants who are eligible through both a year of training and a year of significant mentored research, letters of support should be received from both mentors.

While recognizing that this program is intended to foster the independence of the applicant, FIC recognizes the value of continued collaboration with NIH or U.S. mentors. This relationship should be documented in the application.

Applications must be prepared using the PHS 398 research grant application instructions and forms. Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

D & B number is not necessary for this program because these grants are provided directly to foreign institutions.

3. Submission Dates and Times Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

Prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research

Name, address, and telephone number of the Principal Investigator

Names of other key personnel

Participating institutions

Number and title of this funding opportunity

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by CSR and responsiveness by the FIC.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Supplemental Instructions:

Applicants may request up to two modules, or $50,000, of direct costs per year and the application must be in modular format. The PI is expected to devote at least 50 percent of his/her total effort to this project. The modular grant concept establishes specific modules in which direct costs may be requested, as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach.

It is understood that writing an application for such an R01 grant may be difficult and time-consuming. Therefore, it is encouraged that potential applicants seek assistance in such grant writing. Those being trained via the D43 grant mechanism should seek such assistance at or from their training institutions. Those within the NIH intramural program should seek such guidance within the NIH framework. Although there is a limit of 25 pages for these R01 applications, it is possible that applicants may only need 15 or fewer pages. The application should be complete and follow the format of the PHS 398. Help for completing these applications can be found on the NIH website. Examples of helpful information include:

Applicants will request direct costs in $25,000 modules, up to a total direct cost request of $50,000 per year. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below.

Under Personnel: List all project personnel, including their names, percent of effort, and roles on the project. The PI is expected to devote at least 50 percent of his/her total effort to this project. The PI may only request support of up to 50 percent of his/her effort on this project. The PI's salary and any other salaries should be commensurate with the salary structure at the applicant institution.

Under Facilities and Administrative (F & A) Costs: F & A costs of up to eight percent should be shown under the calculation section on the Checklist page of the PHS 398 application. The F & A cost calculation may not exceed eight percent of total direct costs less equipment. Applicants do not need to complete the section regarding agreements above the calculation section. Applicants should mark the modified total direct costs base box below the calculation section.

Other Requirements:

The applicant should list the date that he/she returned or expects to return to his/her home country.

The applicant must have a letter from the home institution describing its involvement on the ongoing research plan and the support of it including any financial and/or in-kind anticipated support.

For investigators associated with the D43 grants program: include a letter from the U.S. mentor, outlining the nature of the future collaborative relationship, and how the NIH-supported laboratory or other program supported, and/or will support, a continued collaboration with the investigator, using all appropriate resources. The letter should also indicate the dates of research training and a summary of the program.

For applicants eligible through one year of research training and one year of significant mentored research: letters outlining the nature of the future collaborative relationship from both mentors are required. These letters should indicate the dates of such training and research.

In the application, either in the biosketch or as part of the background information, include the specific dates of the training program and, when applicable, the research effort, a description of the training and research programs including the courses taken, and a summary of the program and of the research. Include evidence of at least two years of training or one year of training and one year of significant, well-documented research (i.e., add the specific grant number under which the training was done and the name and contact information of the Principal Investigator).

For NIH Visiting Fellows: include the dates of the training, as well as a letter from the NIH laboratory chief. This letter should also outline the nature of the future collaborative relationships with the NIH mentors.

The investigator must describe current or previous training under the D43 or the NIH intramural program. The applicant must provide a brief paragraph providing the grant number, the name and address of the NIH mentor or Principal Investigator of the D43 or other eligible grant, and a description of the training received. The trainee must have at least two years of such training or one year of such training and one year of significant, well-documented research experience. If the latter, please include the grant number and a summary description of the research experience.

Include two further letters of reference relating to the abilities of the applicant investigator, specifically indicating the ability to become a leader in scientific pursuits. These can be attached at the end of the grant, but before any appendices.

Checklist: this page should be completed and submitted with the application. Applications submitted by foreign or international institutions can request F & A costs up to a maximum of eight percent. Please see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html for more information on the allowability of F & A costs for foreign and international organizations.

Applications not conforming to these guidelines will be considered unresponsive to this PAR and will be returned without further review.

Section V. Application Review Information

1. Criteria Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the FIC.

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.

Receive a written critique

Receive a second level of review by the FIC Advisory Board and possibly the Advisory Boards or Councils of co-sponsors.

The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer review

Availability of funds

Relevance of program priorities

Geographic Balance

Level of need, as measured by economic resources in the applicant's home country

An award will not be made until the applicant has actually returned to his/her home country (or other developing country). A change of grantee institution that involves the transfer of a grant to or between foreign institutions or international organizations requires competitive re-review and approval of the IC Advisory Council/Board.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the health problem that is addressed specifically a priority health issue in the Principal Investigator's home country? If the aims of this project are achieved, how will the Principal Investigator's research career be enhanced?

2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the proposed research hypothesis-driven or hypothesis-generating? (The NIBIB is also interested in technology-driven research that may not specifically be hypothesis-driven.)

3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? How will this award enhance the Principal Investigator's career development and help the Principal Investigator achieve a position of scientific leadership in his/her home country? Do the letters of support document a strong commitment to help the Principal Investigator develop his/her career?

5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Has the Principal Investigator's home institution made a convincing commitment to the Principal Investigator (e.g., provided a research/academic appointment and partial salary support)? What is the continuing commitment of the U.S. collaborating institution (e.g., the institution associated with the NIH D43, the NIH intramural program laboratory, or the research program) to further develop the Principal Investigator's career and research interest?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data Data sharing plan is not required for this program.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates Not applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

The Notice of Grant Award will be sent electronically to the institution email address supplied on the face page of the application. If a grantee is not email enabled, a hard copy of the Notice of Grant Award will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues. Refer to the Fogarty International Center website (http://www.fic.nih.gov) for Frequently Asked Questions.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PAR in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PAR is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.